S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00445848
First received: March 7, 2007
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage IIIB or stage IV primary non-small cell lung cancer who have never smoked.


Condition Intervention Phase
Lung Cancer
Biological: bevacizumab
Drug: erlotinib hydrochloride
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From time of registration to maximum of 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: From time of registration to maximum of 3 years ] [ Designated as safety issue: No ]
  • Response rate (complete and partial) [ Time Frame: From time of registration to maximum of 3 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: From time of registration to maximum of 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: July 2007
Estimated Study Completion Date: July 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib and Bevacizumab Biological: bevacizumab Drug: erlotinib hydrochloride

Detailed Description:

OBJECTIVES:

Primary

  • Assess overall survival of patients with stage IIIB or IV primary non-small cell lung adenocarcinoma who have never smoked and are treated with erlotinib hydrochloride and bevacizumab.

Secondary

  • Assess progression-free survival of patients treated with this regimen.
  • Assess the response rate (confirmed and unconfirmed, complete and partial) in a subset of patients with measurable disease treated with this regimen.
  • Evaluate the frequency and severity of toxicities associated with this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Adenocarcinoma

      • No component of squamous cell carcinoma present
    • Incompletely resected or unresectable disease
  • Stage IIIB or IV disease as defined below:

    • Selected stage IIIB disease

      • T4 (cytologically confirmed malignant pleural effusion OR pleural tumor foci that are separate from direct pleural invasion by the primary tumor)
      • Any N
      • M0
    • Stage IV disease

      • Any T
      • Any N
      • M1 (distant metastases present)
      • Recurrent lung cancer in a separate lobe after resection or radiotherapy within the past 5 years OR multifocal lesions in > 1 lobe considered stage IV disease
  • New lesions occurring ≥ 5 years after resection may be considered a separate primary cancer and are not allowed if this is the only focus of lung cancer
  • Measurable and/or nonmeasurable disease by CT scan, positron emission tomography scan, or MRI

    • Disease must be present outside a previous radiotherapy field OR a new lesion must be inside the port
    • Measurable disease must be assessed within the past 28 days
    • Nonmeasurable disease must be assessed within the past 42 days
    • Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
  • Must be a lifelong nonsmoker (< 100 cigarettes in lifetime)
  • Treated brain metastases allowed provided the patient is asymptomatic and do not require steroids

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Total bilirubin normal
  • SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
  • Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Hypertension allowed if controlled on medication prior to study enrollment
  • Must be willing to provide prior smoking history
  • No immediate life-threatening complications from malignancies
  • No prior major medical condition, psychological condition, or social situation that would preclude study treatment
  • No hemoptysis ≥ ½ teaspoon within the past 28 days
  • No clinical history of pulmonary or upper respiratory hemorrhage ≥ grade 2 within the past 6 months or grade 1 within the past 28 days
  • No history of either thrombosis or hemorrhage, including hemorrhagic or thrombotic stroke, or other CNS bleeding
  • No serious nonhealing wound, ulcer, or bone fracture
  • No other prior malignancy except for the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • Adequately treated stage I or II cancer from which the patient is currently in complete remission
    • In situ cervical cancer
    • Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 7 days since prior fine-needle aspiration or core biopsy
  • At least 28 days since prior radiotherapy (14 days for palliative radiotherapy) and recovered
  • At least 28 days since prior surgery (e.g., thoracic or other major surgeries) and recovered
  • At least 28 days since prior systemic chemotherapy
  • Prior biologic therapy allowed
  • No prior gefitinib, erlotinib hydrochloride, bevacizumab, or other targeted therapies against the epidermal growth factor receptor or vascular endothelial growth factor axes
  • Concurrent stable, therapeutic anticoagulation therapy allowed (e.g., warfarin or low molecular weight heparin), provided the patient has no history of bleeding complications on anticoagulation or an inability to establish a stable therapeutic regimen for anticoagulation
  • No concurrent surgery
  • No other concurrent nonprotocol treatment (including chemotherapy, hormonal therapy, biological therapy, or radiotherapy) directed at this cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445848

  Show 153 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Howard L. West, MD Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00445848     History of Changes
Other Study ID Numbers: CDR0000531056, S0636, U10CA032102
Study First Received: March 7, 2007
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Erlotinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014